Fluid infusion system

ABSTRACT

A fluid infusion system includes an air pump connected to an accumulator tank to produce pressurized air that is stored in the accumulator tank. The system can include one or more fluid bag chambers wherein each fluid bag chamber includes an inflatable bladder positioned inside the fluid bag chamber to apply pressure on the fluid bag supported inside the chamber. The fluid bag can be connected by a tube set to deliver fluid from the fluid bag to a surgical tool at a surgical site. The fluid can, for example, be irrigation fluid or distention fluid. The system can include a controller connected to the pump to control the pump to produce the pressurized air and an adjustable pressure regulator can be connected between the accumulator tank and the inflatable bladder to control the pressure of air delivered to the inflatable bladder and the pressure that the fluid is delivered to the surgical tool. A pressure sensor can be connected between the adjustable pressure regulator and the inflatable bladder to measure the air pressure delivered to the inflatable bladder and send the air pressure measurements to the controller. The controller can configure the system display to show the air pressure measured by the pressure sensor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims any and all benefits as provided by lawincluding benefit under 35 U.S.C. §119(e) of the U.S. ProvisionalApplication No. 62/187,162, filed Jun. 30, 2015, the contents of whichare incorporated herein by reference in its entirety

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not Applicable

REFERENCE TO MICROFICHE APPENDIX

Not Applicable

BACKGROUND

Technical Field of the Invention

The present invention relates to surgery, more particularly, to fluidinfusion systems.

Description of the Prior Art

For a variety of reasons, many minimally invasive gynecologic proceduresare moving from the operating theater with general anesthesia orintravenous sedation to the office with no or minimal anesthesia. Thereasons for this transition include improved efficiency for the patientand physician, reduction in health care cost, and advances in technologythat make these procedures well-tolerated in an office setting. Examplesof such procedures include diagnostic hysteroscopy, tubal sterilization,and removal of uterine polyps. While equipment is changing, thereremains unmet needs including safe delivery and monitoring of fluiddistention during hysteroscopic procedures. Currently, systems designedfor this function can only be found in the operating room due to sizeand cost. Likewise, there is a large percentage of hysteroscopicsurgical procedures that are currently performed in the operating roomthat would benefit from a portable, easy to use and cost efficient fluidpump and management system.

SUMMARY

The present invention is directed to a fluid infusion system that caninclude an air pump connected to an accumulator tank to producepressurized air that is stored in the accumulator tank and one or morefluid bag chamber, wherein each fluid bag chamber can include aninflatable bladder positioned inside the fluid bag chamber to applypressure on a fluid bag supported inside the fluid bag chamber. Thesystem can further include a controller connected to the pump to controlthe pump to produce pressurized air and an adjustable pressure regulatorconnecting the accumulator tank to the inflatable bladder the controlthe pressure of the air that is delivered to the inflatable bladder. Thesystem can include a pressure sensors connected between the adjustablepressure regulator and the inflatable bladder configured to measure theair pressure delivered to the inflatable bladder and send the airpressure measurements to the controller and the controller can configurethe display to show the air pressure measured by the pressure sensor.

In accordance with some embodiments of the invention, the infusionsystem can further include a tubing set connected between the fluid bagsupported inside the fluid bag chamber and a surgical tool to deliverfluid from the fluid bag to the surgical tool at a predefined pressurethat can be adjusted by adjusting the pressure regulator.

In accordance with some embodiments of the invention, the infusionsystem can further include a volume sensor coupled to the inflatablebladder to produce a measure of inflation of the inflatable bladder andtransmit the measure of inflation of the inflatable bladder to thecontroller.

In accordance with some embodiments of the invention, the infusionsystem can be configured wherein the controller receives the measure ofinflation of the inflatable bladder and determines a measure of volumein the fluid bag as a function of the measure of inflation of theinflatable bladder.

In accordance with some embodiments of the invention, the infusionsystem can be configured wherein the volume sensor includes a flexsensor coupled to the inflatable bladder and the flex sensor isconfigured to produce a change in resistance when the flex sensor isflexed as the inflatable bladder is inflated.

In accordance with some embodiments of the invention, the infusionsystem can further include a heater positioned between the inflatablebladder and the fluid bag, wherein the heater is connected to andcontrolled by the controller to warm fluid in the fluid bag.

In accordance with some embodiments of the invention, the infusionsystem can further include a heat sensor in contact with the fluid bagand configured to produce temperature signals representative of themeasured temperature of the fluid in the fluid bag and transmit thetemperature signals to the controller.

In accordance with some embodiments of the invention, the infusionsystem can be configured such that the controller configures the displayto show the temperature of the fluid in the fluid bag and controls theheater as a function of the measured temperature of the fluid in thefluid bag and a predefined temperature set by a user.

In accordance with some embodiments of the invention, the infusionsystem can further include a vacuum pump connected to a vacuum port andconfigured to produce a predefine vacuum pressure (e.g., up to 400 mm Hgor more) at the vacuum port and a suction tube set connected between thevacuum port and a collection reservoir and between the collectionreservoir and the surgical tool to draw waste fluid from a surgicalsite.

In accordance with some embodiments of the invention, the infusionsystem can further include an inflow fluid flow sensor coupled to thetube set to measure a volume of fluid flowing from the fluid bag to thetool and transmit signals representative of the measured fluid volume tothe controller and an outflow fluid flow sensor couple to the suctiontube set to measure a volume of waste fluid flowing from the tool to thecollection reservoir and transmit signals representative of the measuredwasted fluid volume to the controller.

In accordance with some embodiments of the invention, the infusionsystem can further include a surgical drape configured to collect fluidleaking from the surgical site and wherein the suction tube set isconnected between a collection point of the surgical drape and thecollection reservoir to draw was fluid from the collection point intothe collection reservoir. In addition, the controller can be configuredto determine a measure of fluid loss as a function of the receivedsignals representative of the measured fluid volume and the receivedsignals representative of the measured waste fluid volume and configuresthe display to show the measure of fluid loss on the display.

These and other capabilities of the invention, along with the inventionitself, will be more fully understood after a review of the followingfigures, detailed description, and claims.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated into thisspecification, illustrate one or more exemplary embodiments of theinventions and, together with the detailed description, serve to explainthe principles and applications of these inventions. The drawings anddetailed description are illustrative, and are intended to facilitate anunderstanding of the inventions and their application without limitingthe scope of the invention. The illustrative embodiments can be modifiedand adapted without departing from the spirit and scope of theinventions.

FIG. 1 is a diagrammatic view of an infusion system according to anembodiment of the present invention;

FIG. 2 is a diagrammatic view of an infusion system of FIG. 1 showingthe chamber pivot;

FIG. 3 is a diagrammatic view of the infusion system of FIG. 1 withhoses;

FIG. 4 is a block diagram of the infusion system according to anembodiment of the present invention;

FIG. 5 is a front view of the pump assembly;

FIG. 6 is a side view of the upper part of the pump assembly;

FIG. 7 is a detail view of the chamber attachment;

FIG. 8 is a top view of a chamber;

FIG. 9 is a cross-sectional view of the chamber with a full fluid bag;

FIG. 10 is a cross-sectional view of the chamber with an empty fluidbag;

FIG. 11 is a diagram of the fluid bag and hoses;

FIG. 12 is a diagrammatic view of an infusion system according to anembodiment of the present invention; and

FIG. 13 is a flow diagram of an infusion system according to anembodiment of the present invention.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

The present invention is directed to fluid infusion systems that can beused in surgical procedures to supply irrigation fluid and/or distentionfluid to a surgical site. In addition, the fluid infusion system canalso include provide a vacuum source that can be used remove the fluidand other surgical waste from the surgical site. The system according tothe invention is small and light weight enabling it to be used invarious surgical settings including a surgical suite, a clinic and adoctor's office.

In accordance with some embodiments of the invention, as shown in FIGS.1, 2 and 3. In accordance with some embodiments of the invention, thesystem 100 can include a pump assembly 200 and one or more fluid bagchambers 300 (e.g., for supporting saline or other surgical fluids)mounted on an IV pole 110. The fluid bag chamber 300 can house the fluidbag 130 (e.g., saline or other surgical fluids such as irrigation fluidand/or distention fluid), an air bladder 310 to apply pressure on thefluid bag, and a heater 320 to warm the fluid in the fluid bag 130. Thefluid bag 130 can be removable and replaceable. The air bladder 310 canbe permanently or removably mounted inside the fluid bag chamber 300 andconfigured to press against the fluid bag 130 inside the chamber (e.g.,compress the fluid bag against a wall of the chamber). The heater 330can be mounted to the air bladder 320 such that it is between the airbladder 320 and the fluid bag 130 and is in direct contact with thefluid bag 130. The heater 330 can be configured to generate heat that istransferred to the fluid in the fluid bag 130 and raise the temperatureof the fluid in the fluid bag 130.

The pump assembly 200 can be attached to and supported near the fluidbag chamber 300, for example, mounted to the IV pole 110. In accordancewith some embodiments, the pump assembly 200 can be positioned below thefluid bag chambers 300 and the fluid hoses 140 from the fluid bags 120in the chambers 300 can extend along and be positioned (e.g., by gravityor clips 203) adjacent to the pump assembly 200. While the embodimentsof the invention are described in the context of the fluid bag chamber300 and the pump assembly 200 being mounted to an IV pole 110, the fluidbag chambers 300 and the pump assembly 200 can be mounted to any supportstructure, such as a wall, a work station or a table.

In accordance with some embodiments, the pump assembly 200 can beadjustably mounted to a support structure (e.g. an IV pole 110) suchthat its height can be adjusted using a releasable clamp that clamps onthe support structure (e.g., a rod or pole) and can be moved up and downin order to accommodate different heights for convenient viewing of thedisplay and to provide the user with ergonomic access to the controls,for example, during a surgical procedure. The IV Pole 110 or othersupport structure can include wheels 122 at the base 120 to enable it tobe repositioned adjacent the patient.

In accordance with some embodiments of the invention, the pump assembly200, as shown in FIG. 4, can include a controller 210, a touch screendisplay 220, an air pump 230, one or more accumulator tanks 240, apressure regulator 250 (including a rotary dial or knob 252), one ormore Radio Frequency Identification (RFID), Near Field Communication(NFC) and/or barcode readers 280, emergency stop switch, one or morepower supplies 290 (e.g., AC and/or DC), pressure switch 242, and avariety of mechanical interlock switches and safeties that are wired tothe controller 210 in such a way that the pump 230 will only operate ifthe conditions are favorable.

In accordance with some embodiments, the pressurized air runs throughhoses 254 from the pump assembly 200, through or adjacent to the IV pole110 through detachable connectors 256 and 304 to the air bladders 310 inthe fluid bag chambers 300. In accordance with some embodiments of theinvention, the fluid bag chambers 300 can include a heater 320 that isconnected by wires to the controller 210 to enable the controller 210 tocontrol the heater 320 to warm the fluid in the fluid bag 130.Optionally, a temperature control element 290 including for example,power transistors and other components to control the supply power tothe heating element in the heater 320 can be connected between thecontroller 210 and the heater 320.

Existing prior art systems typically use peristaltic pumps or othertypes of pumps that tend to cause the fluid flow to pulsate which cancause erratic movement of tissue in the surgical site during anoperation. In accordance with some embodiments of the invention, thepump assembly 200 can include an air pump 230 that produces compressedor pressurized air that is stored in one or more accumulator tanks 240.The compressed air can be used to inflate the air bladders 310 thatapply pressure on the fluid bags 130 to push the fluid through thesupply tubing 140 of system to the surgical tool 150 (e.g., anendoscope) that can be inserted into the patient at the surgical site.In accordance with some embodiments of the invention, the compressed aircan be produced by a quiet air pump 230 inside the pump assembly housing202 that is capable of producing at least 5 - 20 psi, depending on theprocedure and tools used. Alternatively, the air pump 230 can beremotely located, such as in the base of the IV pole 110 or away fromthe surgical suite or operating room (e.g., the air compressor that ispart of the building infrastructure). The accumulator tanks 240 can besized to accommodate the necessary volume and pressure of air to deliverfluid as needed during a given procedure without the need to turn on thepump 230 or connect the accumulator tank to an external source. In someembodiments, an air hose can connect the pump assembly 200 to thecompressed air connection on the wall of the facility and a valveconnected to the controller 210 (and optionally, a pressure regulator)can be provided in the pump assembly 200 to connect the compressed airto the accumulator tank 240.

In accordance with some embodiments, the compressed air can be sent toand stored in one or more accumulator tanks 240 in the pump assembly200, the base of the IV pole 110 or in any location adjacent thesurgical suite. The accumulator tank 240 acts as a buffer to reduce orprevent the pulsating flow produced by the pump 230 from causing thedelivery of fluid to pulsate. This enables the air bladder 310 to applystable, non-pulsating pressure on the fluid in the fluid bag andprovides for stable (e.g., non-pulsating) and consistent delivery of thefluid to the surgical site. It also provides for rapid response (e.g.,no lag or delay waiting for the pump to build pressure) and allows thepressure to be controlled by a downstream adjustable regulator 250.

In accordance with some embodiments of the invention, the system 100 caninclude one or more accumulator tanks 240 and the size of theaccumulator tank 240 can be selected to provide a predefined volume andpressure to the air bladder 310 to enable the fluid to flow for apredefined amount time or fluid volume. For example, the accumulatortank 240 volume can be configured or selected to hold enough compressedair to drain two or more full fluid bags and/or to last for the entirelength of the surgical procedure in which the fluid is used, without theneed to operate the pump that can cause noise and fluid pulsation duringthe surgical procedure. In accordance with some embodiments of theinvention, two or more accumulator tanks 240 can be used, connected inseries or in parallel between the air pump and the air bladders 310, toenable a predefined volume of air to be stored for the entire durationof a desired surgical procedure.

In accordance with some embodiments of the invention, the accumulatortank 240 can hold a ½ liter of air at maximum pressure of 10-30 psi ormore, to provide sufficient air volume to maintain the fluid pressurewith a desired optimal flow rate. The accumulator tank 240 can beincorporated into the molded pump housing. Alternatively the accumulatortank can be a sealed cylinder that forms part of or is incorporated intothe IV pole and provides multiple connection ports along the length ofthe IV pole.

The volume and pressure for a given system 100 can be determined usingBoyle's Law (e.g., P1 V1=P2 V2) for ideal gases. For example, a typicalsaline (e.g., irrigation or distention fluid) bag holds 1 liter of fluidand the maximum needed pressure to deliver the fluid can be, forexample, 5 PSI. If it is assumed that 2 bags of saline will be usedduring the procedure, the pump and the accumulator tanks can be selectedto provide the necessary performance. For example, the pump 230 andaccumulator tank 240 can be selected to have a max pressure of 20 PSIand the tank can have a volume of at least 0.5 liters. Alternatively,the system can be configured with a 1 liter accumulator tank and a 10psi pump.

In accordance with some embodiments, the air pump 240 can be a small,self-venting diaphragm pump to ensure that the maximum set pressurecannot be exceeded. The air pump 240 can be configured to run when theStart button on the display 220 is pressed and only if a cut-offpressure switch is not triggered (e.g., the pressure inside theaccumulator tank is below a predefined threshold). The system 100 caninclude a pump pressure control circuit that includes an electricalpressure switch 242 that is connected to air accumulator tank240 cancontrols the electric power to the air pump 230. The electric pressureswitch 242 can be configured to remove power to the pump 230 if apressure threshold or maximum pressure (e.g., approximately 20 psi) issensed in the accumulator tank 240. As air is drawn out of the airaccumulator tank 240 into the air bladders 310, the pressure in theaccumulator tank drops below the maximum pressure causing the power tothe pump 230 to be turned back on until the pressure returns to themaximum pressure. As a person having ordinary skill in the art willappreciate, the maximum pressure will vary with the configuration of thesystem 100 according to the invention, including the size and safemaximum pressure of the accumulator tank, as well as the size of thefluid bag, the flow properties of the surgical tool (e.g., the fluidchannel of the endoscope) and the diameter and maximum safe operatingpressure of the tubing 140 connecting the fluid bag 130 to the surgicaltool 150.

In accordance with some embodiments of the invention, the pressurizedair from the accumulator tank 240 flows through tubing to a pressureregulator 250 that maintains the air pressure to the air bladders310—the air pressure can be set by the operator. In accordance with someembodiments the pressure regulator 250 can include a mechanicallycontrolled pressure regulator that enables the user to set the pressureby turning a knob or dial 252 mechanically coupled to the pressureregulator 250. The regulator 250 can be housed inside the pump assembly200 with the regulator control knob 252 extending from the pump assemblyhousing. The position of the pump assembly 200 can be adjusted along theIV pole such that the position of the regulator control knob 252 can bepositioned for easy access by the operator (e.g., without the need tostand up). In accordance with some embodiments of the invention, thepressure regulator 250 can include an electronically controlled pressureregulator that is electrically connected to the controller 210. Thecontroller 201 can figure the display 220 to provide up/down or +/−button icons on the display screen to enable the user to control thepressure (e.g., when the user presses the button icons, the controller210 sends the appropriate signal to the pressure regulator to change theset point pressure. Alternatively, a control knob potentiometer can beused to provide an analog input to the controller 210 to control theelectronic pressure regulator.

In accordance with some embodiments of the invention, as shown in FIG.7, the pressurized air can be routed to the air bladders 310 in thefluid bag chambers 300 through detachable fluid connectors 256 and 304that can also be used to attach the fluid bag chambers 300 to the IVpole 110 (or other support structure). The detachable fluid connectorcan be constructed using a quick connect air fitting that includes amale component 304 that fits into a female component 256 with a slidingsleeve that opens and closes the female component to lock the twocomponents together forming an air tight seal. The fluid connectors canallow the fluid bag chambers to be quickly removed as well as allow thefluid bag chamber to be rotated to facilitate removal and installationof the fluid bags 130. The quick connectors can be installed into asocket to provide additional support when swiveled. Alternatively, aseparate swivel component can be used to connect the fluid bag chamberto the IV pole and a separate tube with detachable connection can beused to connect the air accumulator tank 240 to the air bladder 310.Standard push-to-connect air fittings can be used to provide detachableair connections.

The detachable connector 256, 304 permits the fluid bag chamber 310 topivot on a horizontal axis so that the fluid bag 130 can be invertedsuch that the base of the bag 130 is above the top of the bag 130. Inuse, the filled fluid bag 130 can be hung on a hook 306 inside the fluidbag chamber 310 (with the air bladder compressed) and then the fluid bagchamber 300 can be pivoted so the filled fluid bag 130 is inverted whilethe user spikes the fluid bag 130 (e.g., connects the fluid deliverytubing to the fluid bag). This enables the fluid bag 130 to be connectedto the tubing 140 without experiencing the common problem of fluiddripping from the bag 130 when it is spiked. In accordance with someembodiments, the fluid bag chambers 300 can also include a hingeenabling them to be opened to insert and remove the fluid bag as wellfor priming of the pump (or filling the accumulator tank to maximumpressure) when the enclosure is open and closed. In accordance with someembodiments of the invention, a sensor can be installed on the cover sothe air pump is only activated when the lid is closed. In accordancewith some embodiments of the invention, a spiking mechanism can beincorporated into the fluid bag chamber that allows the distention fluidcontainer to be directly coupled to the inflow tubing without the needto manually spike the fluid bag or container. Alternatively, the airpump 230 can be automatically or manually shut off and/or the airbladder 310 deflated when the chamber 300 is open. This can be done byeither a manual or electrical valve 254 diverting the air pressure toone of 3 different locations: the atmosphere (e.g., venting), sealing itoff (e.g., closing the connection 258 between the air accumulator tank240 and the air bladder 310 in order to fill the accumulator tank), orflow into the airbladder (during operation/run mode). The connection 258can also include a pressure sensor 252 that measures the pressure in theconnection 258 and sends the pressure information to controller 210. Thecontroller 210 can monitor the pressure in the connection 258 andcompare it with upper and lower limits to signal alarms (e.g., pressurelow alarm or pressure high alarm) or change the position of the valve254 if a condition (e.g., the pressure is over the safe limit).

In accordance with some embodiments, the fluid bag chambers 300 can bemolded enclosures that are available in different sizes to match avariety of sizes of fluid bags 130. For example, fluid bag chambers 300can be sized to accommodate standard 500 ml, 1000 ml, 2000 ml, and 3000ml (as well as custom sized) fluid bags 130. In accordance with someembodiments, the fluid bag chambers 300 can be shaped to accommodate theblow-fill-seal containers (e.g., available from Asept Pak Inc in Malone,N.Y.) that are becoming increasing popular for IV fluids as analternative to the standard fluid bags.

As shown in FIGS. 4 and 7-10, the fluid bag chamber 300 according tosome embodiments of the invention can include an inflatable air bladder310, a heater 320, a temperature or heat sensor 322, and a volumemeasuring sensor 312. In accordance with some embodiments, as shown inFIG. 8 the fluid bag chamber 300 can be round or have any tubular shapeand optionally include a side opening (e.g., in addition to a hinge oras an alternative to the hinge) to allow a fluid bag to be easilyinserted or removed. For example, the fluid bag chamber 300 can have a Cor U shaped cross-section. The fluid bag 130 can be inserted into theside, top or bottom opening and hung on a hook 302 at the top of thefluid bag chamber 300 to keep it from falling or collapsing. The bottomof the chamber can be at least partially open to provide access to thebase of the fluid bag 130 so that the bag can be spiked (e.g., connectedto delivery tubing).

The fluid bag chamber 300 according to the invention provides severalimprovements over the prior art. The C-shaped chamber allows for ease ofaccess for inserting and removing fluid bags or other containers. Thepivoting fluid bag chamber 300 enables the fluid bags 130 to pivoted tofacilitate attachment, enabling the user easy access to the connectionport on the fluid bag 130 and permits spiking (e.g., tubing connection)without leaking. The detachable connector 265, 304 can serve severalfunctions—allowing the fluid bag chamber 300 to pivot for ease of use aswell as for compact storage (e.g., the fluid bag chamber 300 can beeasily removed) and for use in an office environment. Systems accordingto the present invention allow for flexibility and expansion as larger(or smaller) sized fluid bag chambers 300 can be easily installed. Thepresent invention is not limited to the C shaped fluid bag chambers 300.In accordance with some embodiments of the invention, the fluid bagchamber 300 can be design and configured to accommodate any size andshape fluid bag 130 (e.g., saline bags) that is available now or in thefuture. This enables the fluid delivery system 100 according to theinvention to be adapted for use in a broad range of surgicalenvironments, include traditional surgical suites as well out-patientclinics and doctor's offices. Likewise, this enables the fluid deliverysystem to be used in a variety of surgical procedures in which a bodycavity (e.g., the urinary bladder, bone joints, uterine cavity, etc.) isdistended with fluid for an operative endoscopic procedure.

In accordance with some embodiments, the pressured air can be routed viatubing from the pressure regulator 250 to a T junction and the fluid bagchambers can be attached by the detachable connectors on each side ofthe T (or Y shaped) junction. In accordance with some embodiments, allof the fluid bag chambers 300 can be configured receive the same airpressure, that is, the air pressure to each chamber 300 is notindividually adjustable. In accordance with some embodiments, thepressurize air can be routed through the T junction and each fluid bagchamber 300 can include a separate pressure regulator 250, such thateach the air pressure in each air bladder 310 is individuallyadjustable.

During use, the air bladders 310 can be initially empty providingsufficient space in the fluid bag chamber 300 to accommodate a fullfluid bag 130. As the air bladder 310 fills, pressure from the airbladder 310 on the fluid bag 130 displaces the fluid from the fluid bagat a constant pressure based on the operators' set point. The pressureregulator 250 serves to maintain the constant pressure in the airbladder and any drop or rise in pressure of the fluid in the fluid bag130 or the tube set 140 will cause the pressure regulator to increase ordrop the air pressure supplied to the air bladder. This enables thesystem 100 to maintain a substantially constant fluid supply pressure(e.g., for both irrigation and distention purposes) during the entireprocedure. The pressure of the dispensed fluid can be determined as afunction of the pressure in the air bladder 310 which can be measured bypressure sensor 262 connected between the air pressure regulator 250 andthe air bladder 310. In accordance with some embodiments, the pressureof the dispensed fluid can be the same as the pressure in the airbladder 310. Alternatively, depending on the size and configuration ofthe tubing set 140 as well as the tool 150, the pressure of thedispensed fluid can vary.

After the fluid bag 130 is empty or the procedure is completed, theoperator can press a button on the pump assembly 200 housing or thedisplay 220 which releases the pressure (e.g., mechanically orelectrically, such as by opening a valve) in and/or to the air bladder310 to deflate the air bladder 310. After the bladder 310 is deflated,the operator can remove the fluid bag 130 and the tube set 140 fordisposal. The chamber 300 is then ready for another fluid bag 130 to beinstalled.

The volume of fluid in the fluid bag can be measured in a variety ofdifferent ways, for example, by measuring directly or indirectly thethickness (and therefore the volume) of the fluid bag 130 or the airbladder 310. In accordance with some embodiments of the invention, oneor more deflection sensors 312 can be located inside the air bladder 310to determine how much fluid remains in the fluid bag 130. For example,as shown in FIGS. 9 and 10 three deflection gauges can be mountedagainst the inner surface of the air bladder, at the top 312A, middle312B and base 312C of the air bladder. The deflection gauges or sensorscan be a “Long Flex Sensor” available from adafruit.com (product id:182)—these sensor change their resistance as the sensor is flexed orbent. For example, a full bag of saline would occupy most of the spaceinside the fluid chamber causing the air bladder to be concave and thedeflection sensors to be concave as well. As the air bladder expands thesurface of the bladder will change from concave to convex and thedeflection sensors would also become convex and change their resistance.If there is a series of deflection sensors on the surface of the airbladder then the average resistance of the 3 sensors should coincidewith the approximate volume of fluid that has been dispensed. Thesensors can be calibrated by dispensing predefined volumes of fluid andrecording the resistance and the resistance change after each volume isdispensed. These values can be stored in memory of the controller 210and used to extrapolate the volume from the resistance values or theaverage of the resistance values. The volume of dispensed fluid and/orthe volume of remaining fluid can be displayed on the screen so theoperator can monitor the fluid dispensed and/or verify there is anappropriate amount of fluid remaining to complete the procedure. Whenthe system is used with a collection drape and vacuum, the volume ofwaste fluid can also be measured and transmitted to the controller 210so that the amount of lost fluid (e.g., such as to intravasation) can bedetermined (e.g., as function of the difference between the dispensedvolume and waste volume) and displayed to the user.

In accordance with some embodiments of the invention, the volume of thefluid bag 130 or the air bladder 310 can determined by measuring thedistance through the fluid bag 130 or the air bladder 310. The distancecould be used to calculate or extrapolate a given volume based on theminimum and maximum distance range measured between a full air bladder310 (e.g., empty saline bag) and empty air bladder 310 (e.g., fullsaline bag). In accordance with some embodiments of the invention, thedistance can be measured using one or more ultrasonic sensors that usethe change in sound signals that pass through (e.g., using a transmitteron one side and a receiver on the other side of) or the fluid bag 130 orthe air bladder 310. In accordance with some embodiments of theinvention, the distance can be measured using one or more ultrasonicsensors that use the change in sound signals that pass through and arereflected back (e.g., using a transmitter and receiver on the same sideof) or the fluid bag or the air bladder. As the thickness of the fluidbag 130 changes, the received sound signals change a function thethickness (e.g., the received signal attenuation or amplitude ascompared to the transmitted signal can change). In accordance with someembodiments of the invention, the distance can be measured using one ormore optical (e.g., infrared or visible light) sensors that use thechange in optical signals that pass through (e.g., using a transmitteron one side and a receiver on the other side of) or the fluid bag or theair bladder. In accordance with some embodiments of the invention, thedistance can be measured using one or more optical (e.g., infrared orvisible light) sensors that use the change in optical signals that passthrough and are reflected back (e.g., using a transmitter and receiveron the same side of) or the fluid bag or the air bladder 310. As thethickness of the fluid bag changes, the optical signals change afunction the thickness (e.g., the received signal attenuation oramplitude as compared to the transmitted signal can change). The volumevalues can be displayed on the screen so the operator can verify thereis an appropriate amount of fluid remaining.

In accordance with some embodiments, an array of sensors can be used tomeasure fluid volume. The volume can be determined as a function of anaverage of two or more sensors or a single sensor can be used to measurevolume. When electrical sensors are used, an electrical connection canbe used to provide power and to send signals back to the controller 210.The signals can be used to calculate the fluid bag 130 volume and thenpresented a graphical or numerical representation on the touch screendisplay showing the volume of fluid used or remaining in the bag.

In accordance with some embodiments, the tube set 140 can include afluid volume sensor that reports the volume of fluid flowing past thevolume sensor to the controller 210. The sensor and the tube set 140 canbe disposable. In accordance with some embodiments, the volume sensorcan include a magnetically coupled impellor that coupled to a sensorthat is part of the pump assembly or the fluid bag chamber that reportsfluid flow through the tube set 140 to the controller 210. In accordancewith some embodiments, the volume sensor can include an ultrasonicsensor that is part of the pump assembly or the fluid bag chamber thatreports fluid flow through the tube set 140 to the controller 210.

In accordance with some embodiments of the invention, the fluid bagchamber 300 can include a heater 320 positioned to be in contact withthe fluid bag 130 installed in the chamber 300. In accordance with someembodiments of the invention, the heating element 320 can be positionedbetween the air bladder 310 and fluid bag 130 such that the heater 320is being pressed against the fluid bag 130 by air bladder 310 duringused. In accordance with some embodiments of the invention, the heater320 can be positioned between the wall of the fluid bag chamber 300 andfluid bag 130. In accordance with some embodiments, the heater 320 caninclude a low power heating element that is not intended to raise thefluid to the desired temperature, but only to maintain the temperatureof the fluid as it is expected that the fluid will be raised to thedesired temperature prior to installing the fluid bag 130 in the chamber300. In accordance with some embodiments, the heater 320 can include ahigher power heating element that can be used to raise the fluid to anydesired temperature.

In accordance with some embodiments, the heater 320 can include one ormore heating elements 322, for example, a 3″×10″, 200-watt siliconeheating element (available from Keenovo (Shanghai, China) or a similarsupplier). The heating element 322 can be mounted to the surface of theair bladder 310 or the inner surface of the fluid bag chamber 300 suchthat the heater 320 is in direct contact with the fluid bag 130. Inaccordance with some embodiments of the invention, the heater caninclude an infrared heater, passing the fluid through a disposableheated tray or manifold, and/or wrapping the fluid hose around a headedcylinder several times to increase the dwell time. In accordance withsome embodiments, a temperature sensor 322 near the base of the bag 130(away from the heating element) or on the tubing 140 connected to thebag 130, can be used to read to actual temperature of the fluid. Inaccordance with some embodiments of the invention, the temperature ofthe fluid from each chamber 300 can be adjusted separately, that is,each chamber can have a different fluid temperature setting.

In accordance with some embodiments of the invention, the fluid bagchamber 300 can include a variety of electrical connections to theelectronic components in the chamber 300. The fluid bag chamber 300 caninclude the following electric components: one or more electric heaters,one or more volume measurement sensors, and one or more temperaturesensors. These electric components can by connected to the controller210 by wires through a separate connector fitting for each sensor or allthe connection can share the same connector fitting. These connectorsallow the wires to be easily disconnected and reconnected when swappingout chambers 300. For example, in some embodiments of the invention, theconnector can be an 8 pin DIN connector that can be easily disconnectedand reconnected when the air chamber is swapped.. In accordance withsome embodiments of the invention, the connector does not pivot with theair connection and the wire provides sufficient slack to enablepivoting. In accordance with some embodiments of the invention, theconnector can pivot as part of the air connection, for example, by beingarranged around the pivot axis of the air connector. For example, theconnector can include a rotary union that has both electrical andpneumatic connections inside, such as a Deublin (Waukegan, Ill.) partnumber 1102-070-082. The rotary union enables quick connection becauseof the dual nature of the coupled pneumatic/electrical contacts.

In accordance with some embodiments of the invention, the system caninclude a fluid bag pre-heater 500 as shown in FIG. 12. The fluid bagpre-heater 500 can include a housing 502 and a heating element 520(e.g., a 3″×10″ or larger, 200-watt silicone heating element availablefrom Keenovo, Shanghai, China or a similar supplier) set at a presettemperature. Unheated bags (at room temperature) can be placed in thepre-heater 500 pre-heating, enabling the fluid (e.g., saline) to get upto a preset temperature (e.g., 98 degrees) more quickly in anticipationof placing the bag into the fluid bag chamber 300. The fluid bagpre-heater can located in or on the base of the IV pole 110. Thelocation of the preheater 500 will lower the center of gravity of thesystem 100 and also allow for the operator to quickly swap out thesaline bag 130 if needed. The pre-heater 500 can be connected the systembattery, a separate battery or configured such that it will only workwhen it is plugged into an AC power outlet.

In accordance with some embodiments of the invention, the system caninclude a battery 410 and battery charging circuitry 412. The battery410 and charging circuitry 412 can be contained in a metal or plastichousing 400 that is mounted at or in the base of the IV pole 110. Thesize of the battery 410 can be selected to allow the unit to be used fora predetermined period of time (e.g., the expected length of a surgicalprocedure, with some margin of safety) so that it can be moved freelyaround the room (the operating room, surgical suite or office) withoutthe need to be tethered to an AC power outlet. The battery housing 400can include a circuit with a display that can display the status of thebattery including the time remaining. In accordance with someembodiments of the invention, the battery 410 can be selected to enablethe system to remain fully operational during procedures that aretypically of short duration, for example, the battery can be sized(e.g., 10 Ah) to run the system for approximately 30 minutes at 250 mmHg(e.g., approx. 5 psi).

The touch screen display 220 can be controlled by the controller 210 topresent a Graphical User Interface (GUI) that enables the user tocontrol the operation of the system 100 by touching icons and controlspresented on the display 220. The touch screen display 220 can include aresistive or capacitive surface that records the location of the contactwith screen and is programmed to perform a function which can change theway the controller 210 and the system 100 operates. A resistive screenis preferred since operators will typically have gloves. Alternatively,mechanical buttons and switches can be provided to control the operationof the system with or without a touch sensitive screen. The screen 220can display the fluid temperature and fluid pressure. A pressure “dial”or other icon (e.g., up/down buttons or +/− buttons) can be presented onthe screen 220 to enable the user to easily adjust the fluid pressure.

A temperature “dial” or other icon (e.g., up/down buttons or +/−buttons) can be presented to the user to enable the user to easilyadjust the fluid temperature. After the tubing set 140 is selected andinstalled, the operator can set the system 100 to the desired orrecommended pressure and temperature within the limits set by theinstalled tubing set 140.

In accordance with some embodiments of the invention, as shown in FIG.11, the tubing set 140 can include a length of tubing selected becauseits physical characteristics make it suitable for a particularprocedure. The tubing set 140 can include at the proximal end, one ormore spike ends 142 for connecting the tubing set 140 to a fluid bag130. The tubing set 140 can include one or more RFID, NFC, and/orbarcode tags 180, one or more valves 144 and at the distal end, afitting (e.g., a Luer Lok TM fitting) for connecting the distal end tothe tool 150. In accordance with some embodiments, the proximal end canbe bifurcated or split into two or more branches to enable the tube set140 to be connected to two or more fluid bags 130.

In accordance with some embodiments of the invention, each tube set 140can include one or more RFID/NFC tag (or a barcode label) 180 that canbe read by a reader 280 connected to the controller 210 of system 100when the tubing set is installed. The RFID or NFC tag (or barcode label)can be attached (e.g., molded into or adhered) to the tubing set atlocation along the tubing such that the tag aligns with an RFID or NFCreader 280 incorporated in the pump assembly 200 or on the IV pole 110and enables the controller 210 through the reader 280 to read the tag180. The pump assembly 200 can be labeled and molded (e.g., with achannel, groove or guide) to facilitate positioning the tubing 140 forproper operation. Optionally, a clip for the tubing 140 can be includedon the outside of the pump assembly to position the tag 180 adjacent thereader 280 in pump assembly 200. The tag 180 can include information(e.g., data values and codes in memory of the tag) that identify thetube set 140 and can be used by the controller 210 to configure thesystem 100 for a predefined surgical procedure associated with one ormore of the data values or codes received from the RFID or NFC tag 180.The tag's 180 data values and codes can include information regardingtube set expiration, reordering, batch information, and unique serialnumbers for each tube set so the tube set cannot be reused for otherprocedures. The data values and codes can include system 100configuration settings including the preferred pressure and temperaturesettings for a predefined surgical procedure as well as system 100limits that define the maximum and/or minimum temperature and/orpressure readings that result in an alarm sounding or the systemshutting down. Similarly, where the tube set 140 includes a barcode 180,the barcode 180 can be positioned to align with a barcode reader thatprovides information to the controller to configure the system for apredefined surgical procedure. In accordance with some embodiments ofthe invention, the RFID tag, the NFC tag or the barcode 180 can providedata or codes that can be used as an entry in an index or lookup tablethat specifies one or more system configuration settings (e.g.,including operational limits and ranges) for a predefined surgicalprocedure or a surgical discipline (e.g., Urology, Orthopedics,Gynecology, etc.) associated with the tube set 140. The system 100configuration settings can include the preferred pressure andtemperature settings for a predefined surgical procedure as well assystem 100 limits that define the maximum and/or minimum temperatureand/or pressure readings that result in an alarm sounding or the systemshutting down.

As shown in FIGS. 5 and 6, the pump assembly 200 can be supported by ormounted on an IV pole 110 or other support structure. The pump assembly200 component can be enclosed in a house as shown with the display 220and the pressure regulator know 252 accessible on the front and a powercord connector 299 and a physical power switch 202 on the back at thebase of the pump assembly 200 housing. The physical power switch 202 caninclude an on/off toggle switch that controls the flow of power to thesystem 100 by breaking connection between the AC/DC power transformer290 and the wall out or breaking the connection to the battery.

After power is connected to the controller 210, either before or afterinitialization, the touch screen can optionally display the version ofsoftware and date on startup along with the company logo. In addition, acalibration countdown is also displayed to identify to the user numberuses left until mandatory calibration. And, a tubing set countdown canbe displayed to reminder the operator to reorder tubing sets.

In operation, after the RFID, NFC or barcode tag 180 is read by thereader 280, the reader 280 transfers the data to the controller 210. Thesoftware in the controller 210 can be configured to setup the softwarethat controls the system 100 for a predefined surgical procedure as wellas control the touch screen display to prompt the user for anyadditional information relating to the specific procedure/tubing setinstalled. The software in the controller 210 can include (or haveaccess to) data tables that identify configuration setting for a giventube set 140. For example, the RFIC, NFC or barcode tag can providenumerical value that is uniquely associated with specific surgicalprocedure (e.g., hysteroscopic polyp removal) and that numerical valuecan be used as an index to a table stored in the memory of thecontroller 210. The controller 210 can obtain the preferred pressure(e.g. 180 mm Hg) and temperature (e.g., 98 deg. F) settings from thetable and set these as the default settings of the system. In addition,one or more fields in the table can be used to setup the displayconfiguration, for example, in a surgical procedure where intravasationis a concern, the controller 210 can be configured to calculate fluidlost as a function of the fluid dispensed and fluid collected and thedisplay can be configured to display the calculated fluid loss duringthe procedure. In addition, the controller 210 can also set a fluid lossthreshold that triggers an alarm. The fluid loss threshold can be apredefined value or can be calculated by prompting the user to inputinformation (e.g., patient weight or other physical characteristics)that can be used to calculate the fluid loss threshold.

In accordance with some embodiments of the invention, the tag 180 can bemolded into one or more of the spikes of the tubing set and the reader280 can be located in the fluid bag chamber 300 in close proximity tothe base of the saline bag 130 spike port so it can be read by thesystem controller 210. Similarly, each bag of consumables (e.g., drapeand tubing sets) used during the procedure can include a tag 180 and thefluid bag chamber 300 or the pump assembly 200 can include a reader 208that collects information about these components from their respectivetags 180, for example, when the user positions the tag 180 near thepre-identified location of the reader 280.

In accordance with some embodiments of the invention, the tag 180 can beon or in the packaging and/or the tubing and drape set and the entirepackage contents can be part of a “lot #” and scanned at the beginningof each procedure. The lot # information can be used for tracking of theentire contents of the package and could involve tracking different setsof information if, for example, the package includes components that mayor may not be used depending upon the needs of the procedure. Forexample, the tubing sets 140 can be provided individually or as part ofa combined package (e.g., a “deluxe package”) that can includeadditional components such as a drape 175 and a suction tube set 160.

In accordance with some embodiments of the invention, the tags caninclude lot number information that can be used to facilitate ordermanagement. For example, each box or package of consumables (e.g., tubesets 130) can be identified with a sequence number, such as “3 of 10.”And the system can be configured to only permit the consumables to beused in sequence (e.g., items “1 of 10” and “2 of 10” must be usedbefore item “6 of 10”). Alternatively, as the consumables get used, thesystem can record instances each time a lot number is used and when thenumber of consumables from a given lot reaches a threshold (e.g. 7 outof a lot of 10), the controller can display a prompt to the user toremind the user to “reorder supplies—currently using 7 of 10”. Thisprompt can either be ignored by pressing “remind me later” or confirmedby pressing “order has been placed”. In addition, each tag can includean item serial number that can be stored in the memory of the controller210 and prior to use, the controller 210 check the item serial number ofthe tube set 130 after it is installed to confirm (e.g., by comparingthe item serial number with those stored in memory) that it is not matchthe item serial number from a prior procedure to prevent it from beingreused.

In accordance with some embodiments of the invention, as shown in FIG.13, after the system 100 is powered on (at 700) either by plugging thedevice in or turning on the power switch, the controller 210 caninitialize itself and present an initial display (e.g., with a “Start”button icon) to the user. After initialization, the controller 210 cancheck (at 702) whether the tube set 140 is connected by reading theRFID/NFC/Barcode 180 on the tubing. If the tubing is not connected, thecontroller 210 can configure the display 220 to prompt the user toinstall the tubing set 140 (at 701) and read RFID/NFC/Barcode toconfigure the system 100. Alternatively, the controller 210 can figurethe display 220 to prompt the user to select a predefined procedure(e.g., from a menu) and then present a menu of possible tubing sets 140that have been designed for the selected procedure. The display 220 canprovide tube set ordering and supplier contact information as well.After the user installs the appropriate tube set 140 and presses the OKbutton icon (at 704), the controller 210 can read the RFID/NFC/Barcode180 and begin the configure the system 100. During the configuration ofthe system 100, the controller 210 through software can evaluate theinventory levels to determine whether to prompt the user to ordertubing. If the number of the tube set from the lot number and size isgreater than a predefined threshold (e.g., number 5 of a lot size of10), the controller 210 can configure the display 220 to prompt the userto order tubing (at 703). The controller 210 can be configured todisplay one or more user responses including a “tubing ordered” icon ora “remind me later” icon. If the tubing ordered icon is selected, thecontroller 210 notes in memory that tubing for the current lot numberhas been reordered. If the remind me later icon is selected, the systemwill remind the user to order tube sets the next time a tube set fromthe same lot number is installed. In the next step, the controller 210configures the display 220 to display the start button (at 708). If thenumber of the tube set from the lot is less than a predefined threshold(e.g., number 5 of a lot size of 10), the controller 201 can configurethe display 220 to instruct the user (at 706) to spike the fluid bag 130and the press the tubing ready button icon on the screen. After the userpresses the tubing ready icon, configures the system and presents thestart button icon on the display 220. At this point, the user can openany valves and removed any claims in the tube set 140 in preparation forthe procedure. The user can press the Start button (at 708) on the touchscreen to turn the pump on and force the air bladder to expand to thepreset pressure causing the fluid to flow from the fluid bag 130 toprime the tubing 140 to remove the air in preparation for the procedure.Once the procedure begins, the pressure can be maintained by theregulator and the pump will intermittently turn on when needed tomaintain the appropriate pressure (typically between 10-15 psi) in theaccumulation tank to support the procedure. The touch screen cancontinue to display the fluid temperature, volume and pressure andpresent touch controls on the screen to enable the user to one or moreof the fluid temperature, volume, and pressure. In accordance with someembodiments, the touch screen can also display tubing information orprovide a touch screen control (e.g., a button or other icon) whenpressed displays information about the tube set 140 (e.g., from theRFID, NFC, or barcode) and optionally, other attached components such asthe suction tube set, the drape, and the waste collection container 170,

In accordance with some embodiments, the pressure adjustment controlknob 252 can be positioned below the touch screen display 220 and thecontroller 210 can configure the display 220 to how the actual (e.g.,measured) pressure in mmHg. The control knob 252 can be used to adjustthe set pressure produced by the pressure regulator 250 to the airbladders 310. In accordance with some embodiments of the invention, apressure sensor 262 can be connected the the regulated side of the airsupply between the pressure regulator 250 and air bladder 310. Pressuresensor 262 can be connected to the controller 210 to provide the airpressure measurement that is displayed on the touch screen.

In accordance with some embodiments of the invention, the touch screen220 can provide touch screen controls to control some or all componentsof the pump assembly 200. For example, the touch screen can include atouch “run/stop” button for initial heating and pump operation to reachthe initial settings. In accordance with some embodiments of theinvention, the touch screen 220 can be configured to any informationthat is useful to the user during the procedure. For example, thedisplay can be configured to display the amount of fluid remaining inthe fluid bag 130 so that it is visible at all times. The amount offluid remaining in the fluid bag can be determined using the volumesensors or flow sensors. In accordance with some embodiments of theinvention, the display can also be configured to shows the fluid deficitcalculated as the difference between fluid used and fluid collected viathe outflow or suction tubing. In accordance with some embodiments ofthe invention, touch screen controls can be available to adjust thefluid temperature and a dial or knob 252 can be used to adjust thefluid/air pressure inside the fluid bag chamber 300. A digital displaycan be used to show the preset recommended pressure and temperaturelimits based on the detected tag 180. The range display can vary basedon predetermined “safe” operating limits of tubing and surgical toolsused. If the safe limits are exceeded an alarm can be programmed tosound warning the operator that an adjustment may need to be made.

In accordance with some embodiments of the invention, the operator canadjust the fluid temperature using “+” and “−” button icons presented onthe touch screen. The buttons can be configured to cycle the systemthrough a set of preset temperatures, typically in the range of from 98°F. to 102° F. The touch screen can display the actual and the settemperatures of the fluid to the user. Optionally, a graphical colorchange (e.g., green) of the displayed temperature can be shown and/oraudible beep can be provided when the actual (e.g., measured) valuematches the set value. Similarly, the displayed temperature can changeto color (e.g. to red) when the temperature exceeds a predefined or setthreshold.

In accordance with some embodiments of the invention, the fluid pressurecan be set with a physical knob 252 connected to the pressure regulator250. The pressure can be adjustable in increments of <10 mmHg over arange of from 0 mmHg to 250 mmHg. In accordance with some embodiments,the air bladder 310 can be deflated by opening a relief valve 262 thatallows the air to be released from the air bladder 310 and then theoperator can push on the bladder to remove any excess air. The reliefvalve 262 can be closed after a full fluid bag 130 is installed in thefluid bag chamber 300 in preparation for use. The relief valve 264 canbe connected between the pressure regulator 250 and the air bladder 310to deflate the air bladder to replace the fluid bag 130. The reliefvalve 264 can also be used as an emergency release valve to relieve thepressure in the air bladder 310 if the sensor 262 measures a pressurethat exceeds a predefined limit, for example, the controller 210 canautomatically open the relief valve 264. The relief valve 264 can beopened by pressing a button icon, such as an emergency stop icon on thedisplay panel 220. Alternatively, a mechanical button or electronicbutton can be directly connected to the relief valve 264 to open thevalve 264 in the event of an emergency.

In accordance with some embodiments, the controller 210 can maintain setvalues for pressure, volume, and temperature throughout the surgical ordiagnostic procedure, displaying the actual (e.g., measured) and setvalues for the temperature, volume, and the pressure on the touch screenthroughout the procedure. If the measured temperature, volume, and/orpressure are not the same as the set values within a preset tolerance,an alarm can be configured to sound (beep). The alarm can be configuredin the software of the controller 210 and utilize preset thresholdsprogrammed in the firmware of the controller 210 or a lookup tablestored in memory of the controller 210. The pressure can be adjustedmechanically using the pressure regulator 250, and an electric pressuresensor 262 can be connected between the pressure regulator 250 and theair bladder 310. The signals from the pressure sensor 262 can be used todetermine the pressure value that is displayed on the display screen220. The signals from the pressure sensor 262 can be used by the system100 software in the controller 210 to monitor and control the operationof the system 100 during the procedure. For example, the measuredpressure can be used, along with physical characteristics of the tubeset 140 and the tool 150 (e.g., internal tube diameter and tool flowcharacteristics) to calculate the fluid flow rate. This information canbe compare to information received from flow sensors incorporated in thetube set and large differences can be cause the system to sound an alarmto warn the user.

The controller 210 can include a processor and associated memory toenable it to execute one or more programs that control the operation ofthe pump assembly 200 and the system 100. The memory can includevolatile and non-volatile memory capable of storing information afterthe power is disconnected. The controller 210 can include a wired (e.g.,Ethernet, USB) or wireless (e.g., WiFi, Bluetooth, Zigbee) connection toallow programs and information to be transferred between the controller210 and other computerized devices. The controller 210 can include aninternal clock which can be used for logging and tracking events. Thecontroller 210 can also compare the date and time of the procedurerelative to the manufacturing date of the tubing set to ensure that thetube set has not expired.

The controller 210 can include a program or function that can log (e.g.store in non-volatile memory) some or all the information related toeach specific procedure performed using the system 100. This informationcan include the date and start time of the procedure, some or all of theRFID, NFC or barcode data as well as some or all of the data retrievedlook up tables using the RFID, NFC or barcode data, the tube set serialno., model no, manufacture date and expiration date, the number of fluidbags used, the fluid pressure, temperature and volume data at the startof the procedure and at periodic increments during the procedure throughthe end of the procedure, and information about the system 100 such asmanufacture date, software versions, maintenance status. For example,the fluid pressure, temperature and volume data can be logged (orrecorded) with a time stamp or the start time can be used and the fluidpressure, temperature and volume data can be logged at predefined timeincrements, such as every 1.0 sec., 2.0 sec., 5.0 sec., 10 sec., 15sec., 30 sec., 1 min., 5 min., 15 min. or longer. Any of thisinformation can be transmitted to the user institution (e.g., hospitalor clinic) to enable them to track the settings that were used for aparticular procedure. Some useful values that may be of interest includethe amount of fluid used over a given timeframe and the entireprocedure, information about any spikes in pressure or, drops inpressure over time (e.g., as an indication of a perforation). Thisinformation can be useful in determining a measure of fluid volumeconsumed over time and the entire procedure.

The logged information can also be used by a maintenance program in thecontroller to display to the user that one or more components of thesystem needs service (e.g., a pump diaphragm or seal needs to bereplaced, an air bladder or regulator or component thereof needs to bereplaced). This information can be transmitted by wire (e.g., Ethernetor USB) or wirelessly (e.g., WiFi, Bluetooth, Zigbee, cellular) to aninstitutional information technology system for archival storage and toupdate or confirm inventory management system information.

In accordance with some embodiments of the invention, the loggedinformation can be wirelessly connected (via Bluetooth or other means)or hardwired to a compact thermal printer allowing the operator to printthe values recorded in the procedure for review at a later date or to beused for tracking, insurance or liability purposes.

In accordance with some embodiments of the invention, the system caninclude a flow rate alarm that is configured by the software of thecontroller 210 to sound if certain conditions are met. For example, thesystem 100 can include operating parameters such as the fluid pressureand volume needed to maintain distention during a procedure. Thesoftware can be configured to monitor the fluid pressure and flow volumeand compare it to the known or expected operating parameters (e.g.,retrieved from memory or from the RFID, NFC or barcode data) for thetube set or the procedure. But if there is a spike or drop in the fluidflow and/or fluid pressure that is greater than a predefined threshold(e.g., 10%, 20%, 30%, 40%, 50%, or more) for longer than a predefinedperiod of time (e.g., 1 sec., 2 sec., 5 sec., 10 sec., 15 sec., 20 sec.,30 sec., or more) the system software could sound an alarm alerting theuser of a potentially abnormal condition. In accordance with someembodiments of the invention, the fluid flow and/or pressure thresholdsand the predefined period of time can calculated using one or morealgorithms or determined empirically. The algorithms can be stored inthe memory of the controller 210 and can be “looked up” using the tubingset information.

In accordance with some embodiments of the invention, the alarm canalert the user to a potentially dangerous condition wherein the organ(e.g., the uterus) has become perforated. The alarm triggered by thisparticular set of conditions can have a unique sound, pitch and/orpattern to alert the user of the potentially dangerous condition. Forexample, in response to the special alarm, the user can inspect thesurgical site to determine if an abnormal volume of the fluid leaked outduring the procedure causing the abnormal condition and if so, clear thealarm. However, if the alarm sounds and there is no visible fluid leak,the user could take action to avoid the potentially dangerous conditionfrom harming the patient. This would require calculations for a drop orincrease respectively in “fluid pressure versus time” or “volume versustime”.

In accordance with some embodiments of the invention, the system caninclude a temperature alarm will sound if the set temperature and actualtemperature differ by a preset amount, for example, 3° F., or if theactual temperature is above the maximum set point. The temperaturesensor is on the opposite side of the saline bag. In the case of anempty bag the sensor would heat up quickly and keep the bag from gettingtoo hot. The temperature is measured via a thermocouple and is directlyconnected to the controller via software. The heating element turns onif the sensor does not detect the max temp has been me. Alternativelythe sensor will turn off the heating element if the temperature has beensatisfied.

In accordance with some embodiments of the invention, the system caninclude one or more Emergency Stop features. The pump assembly caninclude an Emergency Stop (button) on the front that is easilyaccessible by the user. Further, the controller can be configured withan Emergency Stop function that is automatically executed if certainconditions are met, for example, an alarm (e.g., over temperature orover pressure) continues for more than a predefined period of time. Whenthe emergency stop is executed (either pressing the button or as acontroller function) the system can also activate a solenoid or a relayto immediately remove air pressure (e.g., turn off power to the pump andopen any pressure release valves) and turn off the heating elements. Forexample, this can also be initiated by the controller and set to beactivated when the pressure threshold is approximately 25 mmHg higherthan the set point. This difference can be ignored for a predefinedperiod of time when the pressure is adjusted. This will prevent falsetriggers to active an alarm

In accordance with some embodiments of the invention, the system 100 canalso include a vacuum source that is connected to the tool 150 and asurgical drape 170 that can be used to draw waste fluid into acollection container 175. In accordance with some embodiments of theinvention, the vacuum or suction can be produced by a vacuum pump 420(e.g., a diaphragm pump) that can be connected to a vacuum accumulatortank 425 that provides suction (e.g., up to 400 mm Hg or more) at a port427 on the pump assembly 200. In accordance with some embodiments of theinvention, the vacuum or suction can be produced by a vacuum pump 420(e.g., a diaphragm pump) that can be directly connected to the suctionport 427on the pump assembly 200. In accordance with some embodiments ofthe invention, the a pressure regulator can be connected between thevacuum pump or vacuum accumulator tank and the suction port 427 toregulate the vacuum pressure to the suction port 427. In accordance withsome embodiments of the invention, the a flow restrictor or vacuumrelief port/valve can be connected between the vacuum pump or vacuumaccumulator tank and the suction port 427 to regulate the vacuumpressure to the suction port 427. In accordance with some embodiments ofthe invention, a vacuum pump 420 (with or without a connected vacuumaccumulator tank 425) can be housed in the base 400 of the IV pole 110and provide suction at a port 427 on the base 400 housing. The port 427can be connected to a collection reservoir 175 and then to the surgicaltool 150 and surgical drape 170 by a suction tube set 160. The suctiontube set 160 enables the system 100 to draw waste fluid out of surgicalsite through the tool 150 and from the drape 170. The surgical tube set160 can include a valve 164 at the tool 150 and a valve 166 at the drape170 to selectively control the collection of waste fluid at thoserespective locations. The surgical tube set 160 can also include a valve162 between the suction port 427 and the collection reservoir 175 tocontrol the suction applied to the collection reservoir 175. Thecollection reservoir 175 can include a filter sock 176 to filter andcollect tissue and debris for later analysis.

In accordance with some embodiments, the vacuum pump 420 can be runcontinuously to maintain vacuum pressure in the collection reservoir175. The pump 420 can include a vacuum sensor 422 connected to the port427 that can be configured to cut the power to the pump if a presetvacuum pressure is reached. The pump 420 can be configured to operateonly when there is a drop in vacuum below a predefined vacuum pressure(e.g., −5 psi). When a diaphragm pump is used, the vacuum can bemaintained without the need for the pump 420 to run constantly. Thesuction tube set 160 can include one or more flow sensors 172 that canbe connected to the controller 210 and send fluid flow data to thecontroller 210. Software running on the controller 210 can track thefluid volume collected in memory and configure the display screen 220 todisplay the volume of fluid collected. The software running on thecontroller 210 can be configured to continuously or periodicallyrecalculate and update the display of the volume of fluid collected.

In accordance with some embodiments of the invention, the collectionreservoir 175 can be on a scale that continuously weighs the collectionreservoir 175 as it is filled with fluid. The weight can be sent to thecontroller 210 and software running the controller 210 can determine theweight of the fluid (by subtracting the weight of the empty reservoir)and volume of the fluid from the density of the fluid (e.g., saline). Asthe reservoir fills with fluid, the controller 210 can continuously orperiodically update its calculation of the volume and update the display220. In accordance with some embodiments of the invention, thecollection reservoir 175 can be graduated to enable the operator tovisually see how much fluid has been collected.

In accordance with some embodiments of the invention, the system 100 caninclude a funneled drape 170 that collects the fluid that leaks from thesurgical site. One of the suction tubes 160 can be connected to base ofthe drape where the fluid collects to sucked into the tube 160 and drawninto the collection reservoir 170. The collected tissue can be filteredand collected into the filter sock 176. In operation, the pump 420 cancycle on and off to maintain the desired suction. Once the procedure iscomplete the solids collected in the filter sock 176 can be sent to alab for analysis.

In accordance with some embodiments of the invention, a single pump canbe used to produce both air pressure and vacuum by selectivelyconnecting (e.g., using valves controlled by the controller 210) theinflow port of the pump to a suction accumulator tank 425 andselectively connecting (e.g., using valves controlled by the controller210) the outflow port of the pump to the air accumulator tank 240. Inoperation, the controller 210 can charge each accumulator tank with apredefined amount of air pressure and vacuum. The predefined amount canbe sufficient to operate the system 100 without the need to use the pumpduring the procedure. The software in the controller 210 can monitor theaccumulator tank pressures and anticipate the needs for air pressureand/or vacuum and selectively operate the pump to increase the air orvacuum pressure as needed.

Other embodiments are within the scope and spirit of the invention. Forexample, due to the nature of software, functions described above can beimplemented using software, hardware, firmware, hardwiring, orcombinations of any of these. Features implementing functions may alsobe physically located at various positions, including being distributedsuch that portions of functions are implemented at different physicallocations.

Further, while the description above refers to the invention, thedescription may include more than one invention.

What is claimed is:
 1. A fluid infusion system comprising: an air pumpconnected to an accumulator tank to produce pressurized air that isstored in the accumulator tank; one or more fluid bag chamber, eachfluid bag chamber including an inflatable bladder positioned inside thefluid bag chamber to apply pressure to a fluid bag supported inside thefluid bag chamber; a controller connected to the pump to control thepump to produce pressurized air; an adjustable pressure regulatorconnecting the accumulator tank to the inflatable bladder such that airat a predefined pressure is delivered to the inflatable bladder; apressure sensor connected between the adjustable pressure regulator andthe inflatable bladder configured to measure the air pressure deliveredto the inflatable bladder and send the air pressure measurements to thecontroller; a display connected to the controller and configured to showthe air pressure measured by the pressure sensor.
 2. The infusion systemaccording to claim 1 further comprising a tubing set connected betweenthe fluid bag supported inside the fluid bag chamber and a surgical toolto deliver fluid from the fluid bag to the surgical tool at a predefinedpressure that can be adjusted by adjusting the pressure regulator. 3.The infusion system according to claim 2 further comprising a volumesensor coupled to the inflatable bladder to produce a measure ofinflation of the inflatable bladder and transmit the measure ofinflation of the inflatable bladder to the controller.
 4. The infusionsystem according to claim 3 wherein the controller receives the measureof inflation of the inflatable bladder and determines a measure ofvolume in the fluid bag as a function of the measure of inflation of theinflatable bladder.
 5. The infusion system according to claim 3 whereinthe volume sensor includes a flex sensor coupled to the inflatablebladder and the flex sensor is configured to produce a change inresistance when the flex sensor is flexed as the inflatable bladder isinflated.
 6. The infusion system according to claim 1 further comprisinga heater positioned between the inflatable bladder and the fluid bag,wherein the heater is connected to and controlled by the controller towarm fluid in the fluid bag.
 7. The infusion system according to claim 6further comprising a heat sensor in contact with the fluid bag andconfigured to produce temperature signals representative of the measuredtemperature of the fluid in the fluid bag and transmit the temperaturesignals to the controller.
 8. The infusion system according to claim 7wherein the controller configures the display to show the temperature ofthe fluid in the fluid bag and controls the heater as a function of themeasured temperature of the fluid in the fluid bag and a predefinedtemperature set by a user.
 9. The infusion system according to claim 2further comprising a vacuum pump connected to a vacuum port andconfigured to produce a predefine vacuum pressure at the vacuum port; asuction tube set connected between the vacuum port and a collectionreservoir and between the collection reservoir and the surgical tool todraw waste fluid from a surgical site.
 10. The infusion system accordingto claim 9 further comprising an inflow fluid flow sensor coupled to thetube set to measure a volume of fluid flowing from the fluid bag to thetool and transmit signals representative of the measured fluid volume tothe controller; an outflow fluid flow sensor couple to the suction tubeset to measure a volume of waste fluid flowing from the tool to thecollection reservoir and transmit signals representative of the measuredwasted fluid volume to the controller.
 11. The infusion system accordingto claim 10 further comprising a surgical drape configured to collectfluid leaking from the surgical site and wherein the suction tube set isconnected between a collection point of the surgical drape and thecollection reservoir to draw was fluid from the collection point intothe collection reservoir; and wherein the controller determines ameasure of fluid loss as a function of the received signalsrepresentative of the measured fluid volume and the received signalsrepresentative of the measured waste fluid volume and configures thedisplay to show the measure of fluid loss on the display.